NCT03070535

APOE Genotype and Diet Influences on Alzheimer's Biomarkers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

This study involves the collection of cognitive and biomarker responses to HIGH and LOW meals in healthy older adults with and without the APOE E4 genotype. Subjects will eat the meal after an overnight fast, followed by cognitive testing, spinal fluid and blood collection. The HIGH meal will be a meal high in saturated fat and high glycemic index foods vs. LOW meal which will be low in saturated fat and low glycemic index foods.

Detailed description

The purpose of this study is to examine how the risk gene for Alzheimer's disease APOE epsilon 4 (E4) influences acute cognitive responses to different types of meals. The rationale for this study is that we know that a diet high in saturated fat and high glycemic index foods (HIGH diet) is a risk factor for Alzheimer's disease (AD). However we have found paradoxically that a Western style HIGH diet acutely improved cognition in APOE E4 carriers, but worsened cognition in E4 non-carriers. This experiment will examine mechanisms that underlie this differential response between E4 carriers and non-carriers. We will enroll older adults who do not have dementia, half of which will be E4 carriers and the other half will be non-carriers. Both groups will contain equal numbers of men and women. These individuals will undergo two experiments in which they eat either a high or a low fat meal, and then after the meal will undergo several tests. The outcome measures include blood measures of metabolic markers, cognitive tests that are known to be sensitive to changes even after a single meal, and spinal fluid measures of Alzheimer's biomarkers such as beta-amyloid, as well as spinal fluid levels of lipids, glucose and insulin. This study will allow us to test whether high and low fat meals acutely affect cognitive and Alzheimer's biomarkers, and if those changes depend on APOE genotype or gender. It is our hope that this work will contribute to our broader understanding about the risks of diet and AD, to help us understand more about how to prevent and treat this devastating neurological disease.

Conditions

• Alzheimer's Disease; Dementia

Interventions

Type	Name	Description
OTHER	HIGH and LOW meal ingestion	The study will examine CSF biomarker responses to HIGH and LOW meals in 80 men and women with and without the E4 allele in a cross-over design. After an overnight fast, participants will ingest either a HIGH or LOW meal on separate days 3-5 weeks apart in random order. Three hours after meal ingestion, participants will undergo a cognitive battery, followed by spinal fluid collection. Blood samples will also be taken at 7 time points before and after meal ingestion.

Timeline

• Start date: 2016-09-01
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2017-03-03
• Last updated: 2024-03-13

Locations

1 site across 1 country: United States